DepressionNCT00742365
Predicting Effectiveness of Light Treatment for Winter Seasonal Affective Disorder
An observational study of Depression, run by University of Maryland, Baltimore.
Trial summary
This study will evaluate a possible tool for predicting future effectiveness of bright light in treating seasonal affective disorder, winter subtype, and will examine secondary effects of bright light on cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- Bright light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with history of recurrent winter depression
Who may be able to join
- Current major depressive disorder, by structured diagnostic interview (SCID), or current bipolar II disorder, if no prior history of rapid cycling, by SCID
- Prior history of major depressive disorder or bipolar II disorder with seasonal specifier, by SCID
- Score of 21 or greater on Hamilton Rating Scale for Depression - Seasonal Affective Disorder Version (SIGH-SAD), met at three time points (informed consent session, 24 hours prior to first light therapy session, and at first light therapy session)
Who cannot join
- Current bipolar I disorder, psychotic disorder, or cognitive disorder, by SCID
- Illicit drug use in the past year, by self-report, or alcohol abuse by SCID
- History of systemic lupus erythematosus
- History of heart attack or stroke
- No antidepressant, mood stabilizer, or antipsychotic medication treatment 30 days before treatment
- Current occupation involves shift work
Show all 10Show fewer
- Current sensitivity to bright light or vision problems not correctable by glasses, by self-report
- Inability to distinguish colors or see stars at night because of increased light sensitivity, by self-report
- Current suicidal ideation, by self-report during SCID interview
- Women of childbearing potential who are pregnant, nursing, or trying to become pregnant. Female participants of childbearing potential must agree to one of the following types of birth control: oral, transdermal, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide.
About this study
Official title: Predicting Light Treatment's Effectiveness on Reducing Depression and Cardiovascular Risk in Seasonal Affective Disorder
This study will evaluate a possible tool for predicting future effectiveness of bright light in treating seasonal affective disorder, winter subtype, and will examine secondary effects of bright light on cardiovascular risk factors.
Read the detailed description
The winter subtype of seasonal affective disorder (SAD) is characterized by episodes of major depression in the fall and winter, with remission of these episodes in the spring and summer. SAD disrupts the lives of millions of Americans, who experience symptoms such as restless agitation, increased appetite and weight gain, and reduced energy and motivation. Bright light treatment, while shown to be effective in improving SAD in 75% of cases, only causes a full remission in 50% of cases. If doctors had a diagnostic tool to determine which patients would respond to bright light therapy, they could make better decisions about whether to prescribe bright light as treatment. This study will examine a possible diagnostic tool-a single, 1-hour bright light session-for predicting improvement in SAD symptoms over an extended course of bright light treatment. Additionally, because many symptoms of SAD (like weight gain and sedentary lifestyle) correspond to cardiovascular risk, this study will examine whether bright light treatment correlates with improved cardiovascular health.
Participants with SAD will be randomly assigned to first receive a 1-hour session of either bright light or the placebo, red light. Then all participants will switch and receive a 1-hour session of the other type of light. Red light has been accepted as a placebo in previous SAD studies because it does not suppress melatonin or shift circadian rhythms. Before and after each light session, participants will have their SAD symptoms evaluated in a clinical interview and self-report measure. After these two light sessions, all participants will receive instructions for administering bright light treatment on their own at home. For the next 6 weeks, participants will administer the bright light to themselves for 1 hour every morning. Every week they will undergo clinical interviews by phone and will mail in self-report measures, some completed daily and some weekly, to the researchers. The participants will have checkups and interviews in person on Weeks 4 and 6. At the two time periods, SAD symptoms and indicators of cardiovascular risk, such as appetite and sleep loss, will be evaluated. The participant responses to bright light and red light at the initial session will be compared with the participant responses to the subsequent 6-week treatment.
- Conditions
- Depression
- Being tested
- Bright light, Red light placebo
- Keywords
- Seasonal Affective Disorder, Light Therapy, Seasonal Depression, Psychiatric Disorder, Bright Light, Major Depressive Disorder, Bipolar Disorder
- Medical subject headings
- Depression, Seasonal Affective Disorder, Mental Disorders, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright lightDevice
Also called Brite light III light box (Apollo) 10,000 lux.
One hour of exposure to bright light daily upon awakening for 6 weeks.
Red light placeboDevice
Also called Dim red light box (Apollo) 50 lux.
One hour of exposure to red light.
| Study group | Role | What they receive |
|---|---|---|
| A | Participants will be given a 1-hour lab test of bright light treatment, then the bright light treatment for 6 weeks. Receives: Device: Bright light | |
| B | Participants will be given a 1-hour treatment of the red light placebo, then the bright light treatment for 6 weeks. Receives: Device: Red light placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton rating scale for depressional seasonal affective disorder (SIGH SAD)
Measured: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks
Secondary outcomes (8)
Hunger questionnaire
Measured: Measured daily for 6 weeks
Three factor eating questionnaire
Measured: Measured weekly for 6 weeks
Sleep log
Measured: Measured weekly for 6 weeks
Food craving questionnaire
Measured: Measured daily for 6 weeks
Side effects questionnaire
Measured: Measured weekly for 6 weeks
Adherence questionnaire
Measured: Measured weekly for 6 weeks
Profile of Mood States
Measured: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks
Beck Depression Inventory-II (BDI)
Measured: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Teodor Postolache, University of Maryland, Baltimore
- Investigators
- Teodor T. Postolache, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742365
- Sponsor's protocol ID
- HP-00043574
- Other IDs
- R34MH073797, DSIR 83-ATSO, H-28845
- Status last verified
- Nov 2019
- First submitted
- 25 Aug 2008
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Uzoma HN, Reeves GM, Langenberg P, Khabazghazvini B, Balis TG, Johnson MA, Sleemi A, Scrandis DA, Zimmerman SA, Vaswani D, Nijjar GV, Cabassa J, Lapidus M, Rohan KJ, Postolache TT. Light treatment for seasonal Winter depression in African-American vs Caucasian outpatients. World J Psychiatry. 2015 Mar 22;5(1):138-46. doi: 10.5498/wjp.v5.i1.138.
PubMed 25815263Reeves GM, Rohan KJ, Langenberg P, Snitker S, Postolache TT. Calibration of response and remission cut-points on the Beck Depression Inventory-Second Edition for monitoring seasonal affective disorder treatment outcomes. J Affect Disord. 2012 Apr;138(1-2):123-7. doi: 10.1016/j.jad.2011.12.003. Epub 2012 Jan 25.
PubMed 22277151Reeves GM, Nijjar GV, Langenberg P, Johnson MA, Khabazghazvini B, Sleemi A, Vaswani D, Lapidus M, Manalai P, Tariq M, Acharya M, Cabassa J, Snitker S, Postolache TT. Improvement in depression scores after 1 hour of light therapy treatment in patients with seasonal affective disorder. J Nerv Ment Dis. 2012 Jan;200(1):51-5. doi: 10.1097/NMD.0b013e31823e56ca.
PubMed 22210362Virk G, Reeves G, Rosenthal NE, Sher L, Postolache TT. Short exposure to light treatment improves depression scores in patients with seasonal affective disorder: A brief report. Int J Disabil Hum Dev. 2009 Jul;8(3):283-286. doi: 10.1901/jaba.2009.8-283.
PubMed 20686638
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Light Treatment's Effectiveness on Reducing Depression and Cardiovascular Risk in Seasonal Affective Disorder
- ClinicalTrials.gov ID
- NCT00742365
- Acronym / sponsor ID
- HP-00043574
- Conditions
- Depression
- Keywords
- Seasonal Affective Disorder, Light Therapy, Seasonal Depression, Psychiatric Disorder, Bright Light, Major Depressive Disorder, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a possible tool for predicting future effectiveness of bright light in treating seasonal affective disorder, winter subtype, and will examine secondary effects of bright light on cardiovascular risk factors.
Detailed description
The winter subtype of seasonal affective disorder (SAD) is characterized by episodes of major depression in the fall and winter, with remission of these episodes in the spring and summer. SAD disrupts the lives of millions of Americans, who experience symptoms such as restless agitation, increased appetite and weight gain, and reduced energy and motivation. Bright light treatment, while shown to be effective in improving SAD in 75% of cases, only causes a full remission in 50% of cases. If doctors had a diagnostic tool to determine which patients would respond to bright light therapy, they could make better decisions about whether to prescribe bright light as treatment. This study will examine a possible diagnostic tool-a single, 1-hour bright light session-for predicting improvement in SAD symptoms over an extended course of bright light treatment. Additionally, because many symptoms of SAD (like weight gain and sedentary lifestyle) correspond to cardiovascular risk, this study will examine whether bright light treatment correlates with improved cardiovascular health.
Participants with SAD will be randomly assigned to first receive a 1-hour session of either bright light or the placebo, red light. Then all participants will switch and receive a 1-hour session of the other type of light. Red light has been accepted as a placebo in previous SAD studies because it does not suppress melatonin or shift circadian rhythms. Before and after each light session, participants will have their SAD symptoms evaluated in a clinical interview and self-report measure. After these two light sessions, all participants will receive instructions for administering bright light treatment on their own at home. For the next 6 weeks, participants will administer the bright light to themselves for 1 hour every morning. Every week they will undergo clinical interviews by phone and will mail in self-report measures, some completed daily and some weekly, to the researchers. The participants will have checkups and interviews in person on Weeks 4 and 6. At the two time periods, SAD symptoms and indicators of cardiovascular risk, such as appetite and sleep loss, will be evaluated. The participant responses to bright light and red light at the initial session will be compared with the participant responses to the subsequent 6-week treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Bright lightParticipants will be given a 1-hour lab test of bright light treatment, then the bright light treatment for 6 weeks. |
| B | – | Device: Red light placeboParticipants will be given a 1-hour treatment of the red light placebo, then the bright light treatment for 6 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with history of recurrent winter depression
Key inclusion criteria (3 listed)
- Current major depressive disorder, by structured diagnostic interview (SCID), or current bipolar II disorder, if no prior history of rapid cycling, by SCID
- Prior history of major depressive disorder or bipolar II disorder with seasonal specifier, by SCID
- Score of 21 or greater on Hamilton Rating Scale for Depression - Seasonal Affective Disorder Version (SIGH-SAD), met at three time points (informed consent session, 24 hours prior to first light therapy session, and at first light therapy session)
Key exclusion criteria (10 listed)
- Current bipolar I disorder, psychotic disorder, or cognitive disorder, by SCID
- Illicit drug use in the past year, by self-report, or alcohol abuse by SCID
- History of systemic lupus erythematosus
- History of heart attack or stroke
- No antidepressant, mood stabilizer, or antipsychotic medication treatment 30 days before treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright lightAlso: Brite light III light box (Apollo) 10,000 lux.One hour of exposure to bright light daily upon awakening for 6 weeks. | Device | A |
| Red light placeboAlso: Dim red light box (Apollo) 50 lux.One hour of exposure to red light. | Device | B |
Primary outcome
Hamilton rating scale for depressional seasonal affective disorder (SIGH SAD)
Time frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks
8 secondary outcomes
Hunger questionnaire
Time frame: Measured daily for 6 weeks
Three factor eating questionnaire
Time frame: Measured weekly for 6 weeks
Sleep log
Time frame: Measured weekly for 6 weeks
Food craving questionnaire
Time frame: Measured daily for 6 weeks
Side effects questionnaire
Time frame: Measured weekly for 6 weeks
Adherence questionnaire
Time frame: Measured weekly for 6 weeks
Profile of Mood States
Time frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks
Beck Depression Inventory-II (BDI)
Time frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 25815263Uzoma HN, Reeves GM, Langenberg P, Khabazghazvini B, Balis TG, Johnson MA, Sleemi A, Scrandis DA, Zimmerman SA, Vaswani D, Nijjar GV, Cabassa J, Lapidus M, Rohan KJ, Postolache TT. Light treatment for seasonal Winter depression in African-American vs Caucasian outpatients. World J Psychiatry. 2015 Mar 22;5(1):138-46. doi: 10.5498/wjp.v5.i1.138.
- Background: PubMed 22277151Reeves GM, Rohan KJ, Langenberg P, Snitker S, Postolache TT. Calibration of response and remission cut-points on the Beck Depression Inventory-Second Edition for monitoring seasonal affective disorder treatment outcomes. J Affect Disord. 2012 Apr;138(1-2):123-7. doi: 10.1016/j.jad.2011.12.003. Epub 2012 Jan 25.
- Background: PubMed 22210362Reeves GM, Nijjar GV, Langenberg P, Johnson MA, Khabazghazvini B, Sleemi A, Vaswani D, Lapidus M, Manalai P, Tariq M, Acharya M, Cabassa J, Snitker S, Postolache TT. Improvement in depression scores after 1 hour of light therapy treatment in patients with seasonal affective disorder. J Nerv Ment Dis. 2012 Jan;200(1):51-5. doi: 10.1097/NMD.0b013e31823e56ca.
- Background: PubMed 20686638Virk G, Reeves G, Rosenthal NE, Sher L, Postolache TT. Short exposure to light treatment improves depression scores in patients with seasonal affective disorder: A brief report. Int J Disabil Hum Dev. 2009 Jul;8(3):283-286. doi: 10.1901/jaba.2009.8-283.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teodor T. Postolache, MD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University of Maryland, Baltimore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton rating scale for depressional seasonal affective disorder (SIGH SAD) (time frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00742365, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.